510(k) Report

FDA product code · Cardiovascular

Antimicrobial Blood Pressure Cuff

OEDClass II21 CFR 870.1120510(k) required2 decisions since 20070 recalls

2 FDA decisions since 2007. No recall names this code. The most-cited predicate is K071885, named by 4 later devices.

Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of OED at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OED

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OED

Too few OED 510(k)s in any year since 2007 to give a median.

Recalls per year · OED

No recall names OED since 2007.

Adverse event reports per year · OED

8in 2025

2022: 12025: 8
2007high 8 (2025) · low 0 (2007)2025

MAUDE reports naming product code OED, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—08
20260—0—
FIG. 1 — OED by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OED? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OED devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K071885Antimicrobial and Single-Patient CuffsPhilips Medical Systems · 20074cite it

Which OED devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K122365Ultracheck Curve Blood Pressure CuffsStatcorp Medical · 20132generations
  • K071885Antimicrobial and Single-Patient CuffsPhilips Medical Systems · 20071generation

What has FDA decided in OED lately?

  • K122365Ultracheck Curve Blood Pressure CuffsStatcorp Medical · 2013
  • K071885Antimicrobial and Single-Patient CuffsPhilips Medical Systems · 2007

All 2 OED decisions →

Related product codes

Other codes under 21 CFR 870.1120.

NPP Reprocessed Blood Pressure CuffDXQ Blood Pressure Cuff